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Simvastatin - Prescription Drug Labeling

Product NDC Code 65841-065
Drug Name

Simvastatin

Type Generic
Pharm Class HMG-CoA Reductase Inhibitor [EPC],
Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
Active Ingredients
Simvastatin 5 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 198211,
200345,
312961,
312962,
314231
Application Number ANDA077837
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-065-05 500 tablet, film coated in 1 bottle (65841-065-05)
65841-065-06 30 tablet, film coated in 1 bottle (65841-065-06)
65841-065-10 1000 tablet, film coated in 1 bottle (65841-065-10)
65841-065-14 60 tablet, film coated in 1 bottle (65841-065-14)
65841-065-16 90 tablet, film coated in 1 bottle (65841-065-16)

Spl product data elements

Usually a list of ingredients in a drug product.
Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE WHITE OVAL ZA19 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID FERRIC OXIDE RED FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE PINK OVAL ZA20 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE BROWN OVAL ZA21 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE PINK OVAL ZA22 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE CAPSULE ZA23

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-065-16 in bottle of 90 tablets Simvastatin Tablets USP, 5 mg Rx only NDC 65841-066-16 in bottle of 90 tablets Simvastatin Tablets USP, 10 mg Rx only NDC 65841-067-16 in bottle of 90 tablets Simvastatin Tablets USP, 20 mg Rx only NDC 65841-068-16 in bottle of 90 tablets Simvastatin Tablets USP, 40 mg Rx only NDC 65841-069-16 in bottle of 90 tablets Simvastatin Tablets USP, 80 mg Rx only Simvastatin tablets 5 mg Simvastatin tablets 10 mg Simvastatin tablets 20 mg Simvastatin tablets 40 mg Simvastatin tablets 80 mg

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API